Events

Rappel de INTELLISPACE PORTAL HX

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par PHILIPS ELECTRONICS LTD..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    85367
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2012-05-25
  • Pays de l'événement
    Canada
  • Source de l'événement
    HC
  • Notes / Alertes
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Notes supplémentaires dans les données
  • Cause
    Philips has identified software and user issues with specific applications and options running on the intellispace portal (isp) with software version 4.0 or version 4.0.1 that if the issues were to re-occur it could pose a risk for the patient. software issues: 1. when the user chooses to launch different patient studies directly from the pacs archive into portal applications (pacs integration configuration) the system does not warn the user that a different patient study has been selected for viewing. 2. discrepancies in colors and size of the affected area were observed when the customer uses the "time sensitive" and "time insensitive" methods a sub option of the brain perfusion option. user issue: in the multi-modality tumor tracking application discrepancies in lesion measurements were observed when edits were made to the contours and the editing tool was not closed before moving onto another lesion or stage.

Device

INTELLISPACE PORTAL HX
  • Modèle / numéro de série
    Model Catalog: 4598 001 30491 (Lot serial: ); Model Catalog: 4598 001 31131 (Lot serial: N/A FOR ALL)
  • Description du dispositif
    INTELLISPACE PORTAL HX
  • Manufacturer
    PHILIPS ELECTRONICS LTD.

Manufacturer

PHILIPS ELECTRONICS LTD.
  • Adresse du fabricant
    MARKHAM
  • Société-mère du fabricant (2017)
    Philips
  • Source
    HC